EpilepsyPhase 3NCT00236756
A Study of the Efficacy and Safety of Topiramate as an add-on Therapy in the Treatment of Epilepsy Patients With Lennox-Gastaut Syndrome
A Phase 3 study testing topiramate in people with Epilepsy and Seizures, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of topiramate as add-on therapy in the treatment of epilepsy patients with Lennox-Gastaut syndrome, a severe form of epilepsy in which there are mixed types of seizures. Read more about this study
- Who is it for?
- Ages 12 months to 30 years
- What is being tested?
- topiramate
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 1993to Feb 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Body weight of at least 25 pounds
- diagnosis of Lennox-Gastaut syndrome and an electroencephalogram (EEG) with an abnormal pulsation pattern
- atypical absence seizures and drop attacks (i.e., tonic-atonic seizures) among other seizure types that could include tonic-clonic, myoclonic, and minor-motor
- at least 60 seizures during the month before baseline
- must be maintained on 1 or 2 antiepileptic drugs
- females must not have had their first menstrual period, or are physically incapable of child bearing, or if of child bearing potential, sexually abstinent, or using adequate contraceptive measures, and have a negative pregnancy test before study entry.
Who cannot join
- Patients whose seizures are due to a progressive disease (for example, active infection, cancer or metabolic disturbance)
- have a significant recent history (within 2 years) of medical diseases (respiratory, heart, gastrointestinal, blood diseases, rheumatic fever or cancer)
- history of alcohol or drug abuse.
About this study
Official title: A Double-Blind Trial of Topiramate in Subjects With Lennox-Gastaut Syndrome.
The purpose of this study is to evaluate the effectiveness and safety of topiramate as add-on therapy in the treatment of epilepsy patients with Lennox-Gastaut syndrome, a severe form of epilepsy in which there are mixed types of seizures.
Read the detailed description
Lennox-Gastaut syndrome is a severe form of epilepsy that usually develops in children 4 years of age and younger. It is characterized by several seizure types and developmental delay. Tonic seizures, in which the muscle tone is greatly increased and body, arms and legs make sudden stiffening movements, is particularly common in Lennox-Gastaut syndrome. Although atonic seizures, in which there is a sudden loss of muscle tone and strength, can occur in individuals with this syndrome. Control of seizures is difficult because they are usually resistant to antiepileptic drugs. Topiramate is a drug that is currently widely used for the treatment of seizures in adults and pediatric patients (2 to 16 years of age). This is a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of topiramate as an add-on therapy in patients with Lennox-Gastaut syndrome. The study is composed of two phases: baseline (28 days) and double-blind treatment (approximately 11 weeks). Patients or their guardians/parents are given diaries to record information on seizures occurring during the study. During the baseline phase, the patient continues to receive the antiepileptic drug they have been taking. The double-blind phase is divided into two periods: titration, in which the topiramate dose was gradually increased (21 days) (patient's antiepileptic drug continues; this dose remains the same) and maintenance (56 days). The dose of both topiramate and the patient's antiepileptic drug remain constant during the maintenance period. Based on the investigator's judgment, all patients completing the double-blind period could be enrolled into an extension phase of the study. The primary assessment of effectiveness is the percent reduction from baseline in seizure rates (all types of seizures) in the double-blind phase. Safety assessments include the frequency of adverse events, results of clinical laboratory tests (hematology, biochemistry, and urinalysis), measurements of vital signs and body weight, physical examination and electrocardiogram findings, and neurological examinations. The study hypothesis is that topiramate is superior to placebo in reducing the seizure rate from baseline in the double blind phase of the study and is well tolerated. Topiramate (25milligram [mg] or 100mg tablets) or placebo, taken by mouth, starting at a dose of 1mg/kilogram(kg)/day, gradually increasing over 3 weeks to a total dose of 6mg/kg/day (given twice daily in equal oral doses for 8 weeks). Maximum daily dose is <=600mg/day.
- Being tested
- topiramate
- Keywords
- Epilepsy, Seizures, Topiramate, Prophylaxis, Antiepileptic, Lennox-Gastaut syndrome, Seizures, tonic
- Medical subject headings
- Epilepsy, Seizures, Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topiramateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction from baseline in seizure rates (all types of seizures) in the double-blind phase. Percent reduction in drop attacks (tonic-clonic) and parent/guardian global evaluation at end of study
Secondary outcomes (1)
Percent treatment responders all types of seizures. Percent treatment responders drop attacks (tonic-clonic seizures). Safety evaluations conducted throughout the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startAug 1993
- Study completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236756
- Sponsor's protocol ID
- CR005464
- Status last verified
- Jan 2011
- First submitted
- 7 Oct 2005
- Last updated
- 3 Jun 2011
- Results posted
- No
Publications
Sachdeo RC, Glauser TA, Ritter F, Reife R, Lim P, Pledger G. A double-blind, randomized trial of topiramate in Lennox-Gastaut syndrome. Topiramate YL Study Group. Neurology. 1999 Jun 10;52(9):1882-7. doi: 10.1212/wnl.52.9.1882.
PubMed 10371538Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4.
PubMed 33825230
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Trial of Topiramate in Subjects With Lennox-Gastaut Syndrome.
- ClinicalTrials.gov ID
- NCT00236756
- Acronym / sponsor ID
- CR005464
- Keywords
- Epilepsy, Seizures, Topiramate, Prophylaxis, Antiepileptic, Lennox-Gastaut syndrome, Seizures, tonic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Aug 1993
- Study completion
- Feb 2001 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness and safety of topiramate as add-on therapy in the treatment of epilepsy patients with Lennox-Gastaut syndrome, a severe form of epilepsy in which there are mixed types of seizures.
Detailed description
Lennox-Gastaut syndrome is a severe form of epilepsy that usually develops in children 4 years of age and younger. It is characterized by several seizure types and developmental delay. Tonic seizures, in which the muscle tone is greatly increased and body, arms and legs make sudden stiffening movements, is particularly common in Lennox-Gastaut syndrome. Although atonic seizures, in which there is a sudden loss of muscle tone and strength, can occur in individuals with this syndrome. Control of seizures is difficult because they are usually resistant to antiepileptic drugs. Topiramate is a drug that is currently widely used for the treatment of seizures in adults and pediatric patients (2 to 16 years of age). This is a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of topiramate as an add-on therapy in patients with Lennox-Gastaut syndrome. The study is composed of two phases: baseline (28 days) and double-blind treatment (approximately 11 weeks). Patients or their guardians/parents are given diaries to record information on seizures occurring during the study. During the baseline phase, the patient continues to receive the antiepileptic drug they have been taking. The double-blind phase is divided into two periods: titration, in which the topiramate dose was gradually increased (21 days) (patient's antiepileptic drug continues; this dose remains the same) and maintenance (56 days). The dose of both topiramate and the patient's antiepileptic drug remain constant during the maintenance period. Based on the investigator's judgment, all patients completing the double-blind period could be enrolled into an extension phase of the study. The primary assessment of effectiveness is the percent reduction from baseline in seizure rates (all types of seizures) in the double-blind phase. Safety assessments include the frequency of adverse events, results of clinical laboratory tests (hematology, biochemistry, and urinalysis), measurements of vital signs and body weight, physical examination and electrocardiogram findings, and neurological examinations. The study hypothesis is that topiramate is superior to placebo in reducing the seizure rate from baseline in the double blind phase of the study and is well tolerated. Topiramate (25milligram [mg] or 100mg tablets) or placebo, taken by mouth, starting at a dose of 1mg/kilogram(kg)/day, gradually increasing over 3 weeks to a total dose of 6mg/kg/day (given twice daily in equal oral doses for 8 weeks). Maximum daily dose is <=600mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 months to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Body weight of at least 25 pounds
- diagnosis of Lennox-Gastaut syndrome and an electroencephalogram (EEG) with an abnormal pulsation pattern
- atypical absence seizures and drop attacks (i.e., tonic-atonic seizures) among other seizure types that could include tonic-clonic, myoclonic, and minor-motor
- at least 60 seizures during the month before baseline
- must be maintained on 1 or 2 antiepileptic drugs
Key exclusion criteria (3 listed)
- Patients whose seizures are due to a progressive disease (for example, active infection, cancer or metabolic disturbance)
- have a significant recent history (within 2 years) of medical diseases (respiratory, heart, gastrointestinal, blood diseases, rheumatic fever or cancer)
- history of alcohol or drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topiramate | Drug | – |
Primary outcome
Percent reduction from baseline in seizure rates (all types of seizures) in the double-blind phase. Percent reduction in drop attacks (tonic-clonic) and parent/guardian global evaluation at end of study
1 secondary outcome
Percent treatment responders all types of seizures. Percent treatment responders drop attacks (tonic-clonic seizures). Safety evaluations conducted throughout the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2011.
- Results publication: PubMed 10371538Sachdeo RC, Glauser TA, Ritter F, Reife R, Lim P, Pledger G. A double-blind, randomized trial of topiramate in Lennox-Gastaut syndrome. Topiramate YL Study Group. Neurology. 1999 Jun 10;52(9):1882-7. doi: 10.1212/wnl.52.9.1882.
- Derived from this study: PubMed 33825230Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4.
- A study of the efficacy and safety of topiramate in patients with Lennox-Gastaut syndromeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing topiramate in people with Epilepsy and Seizures, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction from baseline in seizure rates (all types of seizures) in the double-blind phase. Percent reduction in drop attacks (tonic-clonic) and parent/guardian global evaluation at end of study. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00236756, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2011.